ORA.FSTD.240 Record-keeping

FSTD RECORDS

(a)FSTD records to be kept should include the following:

(1)for the lifetime of the device:

(i)the master QTG (MQTG) of the initial evaluation;

(ii)the qualification certificate of the initial evaluation; and

(iii)the initial evaluation report;

(2)for a period of at least 5 years (in paper or electronic format):

(i)recurrent QTG runs;

(ii)recurrent evaluation reports;

(iii)reports of internal functions and subjective testing;

(iv)technical log;

(v)CMS report;

(vi)audit schedule;

(vii)evaluation programme;

(viii)management evaluation reports;

(ix)obsolete procedures and forms.